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Multicenter prospective cross-sectional study of CD patients, its aim is the construction of an objective and reproducible system for evaluation of Transmural healing in Crohn's Disease (CD).
Primary objective : Objective definition of depth or grade of transmural healing in relation to radiologic signs observed during Magnetic Resonance Enterography (MRE) in CD
Number of patients : 210 patients, in 14 sites (only one investigator per site), 15 patients per site, 5 patients per grade of transmural healing based on the appraisal of a local reader pair (a gastroenterologist and a radiologist).
Recruitment period : 2 years
Primary Endpoint : Objective definition of depth or grade of transmural healing in relation to radiologic signs observed during Magnetic Resonance Enterography (MRE) in CD
Secondary Endpoints :
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnetic Resonance Enterography (MRE) | Procedure | MRE performed as part of the standard of care follow up of the patient, the exam will be recorded for the study and analysed by central readers. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective definition of depth or grade of transmural healing in relation to radiologic signs observed during Magnetic Resonance Enterography (MRE) in CD | An index (depth of remission) or score (grade of remission) will be constructed through multiple linear or logistic mixed regression models. | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Intra- and inter-observer variability of lesions observed per segment during MRE in CD | Variations in MRE readings images between the CR will be quantified through the Kappa coefficient for qualitative items and through the intraclass correlation coefficient for quantitative items. | Day 1 |
| Intra- and inter-observer variability of depth and grade of global transmural healing in CD |
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Inclusion Criteria:
Exclusion Criteria:
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Patients diagnosed with CD for more than 6 months with histological confirmation available in his medical record, with an indication for MRE based on routine clinical practice validated by the treating physician
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sophie GEYL | Contact | +33 5 55 05 66 31 | sophie.geyl@chu-limoges.fr | |
| Laurent PEYRIN-BIROULET | Contact | +33 3 83 15 36 61 | peyrinbiroulet@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Sophie GEYL | CHU Limoge Dupuytren | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Liège | Not yet recruiting | Liège | 4000 | Belgium |
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Blood serum, stool.
Variations in MRE readings images between the CR will be quantified through the Kappa coefficient for qualitative items and through the intraclass correlation coefficient for quantitative items. |
| Day 1 |
| CHU Amiens-Picardie (site Sud) | Recruiting | Amiens | 80054 | France |
|
| CHU de Bordeaux - Hôpital Haut-Lévêque | Not yet recruiting | Bordeaux | 33600 | France |
|
| APHP - Hôpital Ambroise Paré | Not yet recruiting | Boulogne-Billancourt | 92100 | France |
|
| CHU de Clermont-Ferrand - Hôpital d'Estaing | Recruiting | Clermont-Ferrand | 63003 | France |
|
| APHP - Hôpital Louis Mourier | Not yet recruiting | Colombes | 92700 | France |
|
| CHRU de Lille - Hôpital Claude Huriez | Not yet recruiting | Lille | 59037 | France |
|
| CHU Limoges Dupuytren | Recruiting | Limoges | 87000 | France |
|
| AP-HM - Hôpital Nord | Not yet recruiting | Marseille | 13015 | France |
|
| CHU de Montpellier - Hôpital Saint Eloi | Recruiting | Montpellier | 34295 | France |
|
| CHU de Nantes | Not yet recruiting | Nantes | 44093 | France |
|
| CHU de Nice - Hôpital l'Archet II | Not yet recruiting | Nice | 06200 | France |
|
| CHU de Nîmes - Hôpital Carémeau | Not yet recruiting | Nîmes | 30029 | France |
|
| APHP - Hôpital Européen Georges Pompidou (HEGP) | Not yet recruiting | Paris | 75908 | France |
|
| Hospices Civils de Lyon | Not yet recruiting | Pierre-Bénite | 69475 | France |
|
| CHU Rennes - Hôpital Pontchaillou | Not yet recruiting | Rennes | 35033 | France |
|
| CHU de Saint Etienne - Hôpital Nord | Not yet recruiting | Saint-Priest-en-Jarez | 42270 | France |
|
| CHRU de Nancy - Hôpitaux de Brabois | Not yet recruiting | Vandœuvre-lès-Nancy | 54500 | France |
|
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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